A Randomized Study To Evaluate Efficacy And Safety Of A Fixed Combination Therapy Of Amlodipine And Atorvastatin
NCT ID: NCT00530946
Last Updated: 2021-01-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
165 participants
INTERVENTIONAL
2007-09-30
2008-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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CI-1038 2.5mg/5mg
Amlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
CI-1038 2.5mg/10mg
Amlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
CI-1038 5mg/5mg
Amlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
CI-1038 5mg/10mg
Amlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
Interventions
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Amlodipine 2.5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
Amlodipine 2.5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 5mg
Single pill combination, dosed once daily for 8 weeks
Amlodipine 5mg/Atorvastatin 10mg
Single pill combination, dosed once daily for 8 weeks
Eligibility Criteria
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Inclusion Criteria
* The SBP at Visit 4 (Week -1) and Visit 5 (Week 0) is continuously SBP \>=140 mmHg and \<180 mmHg,
* LDL-C \>=140 mg/dL and \<250 mg/dL at Visit 3 (Week -2) and 4 (Week -1).
Exclusion Criteria
* Myocardial infarction
* Receiving PCI（percutaneous coronary intervention）or CABG (coronary artery bypass grafting)
* Any clinically meaningful valvular disease
* Subjects with a history of cerebrovascular diseases such as stroke or transient ischemic attack within the past 3 months.
20 Years
79 Years
ALL
No
Sponsors
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Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Fukuoka, Fukuoka, Japan
Pfizer Investigational Site
Kitakyushu-shi, Fukuoka, Japan
Pfizer Investigational Site
Kurume-shi, Fukuoka, Japan
Pfizer Investigational Site
Maebaru-shi, Fukuoka, Japan
Pfizer Investigational Site
Annaka, Gunma, Japan
Pfizer Investigational Site
Sapporo, Hokkaido, Japan
Pfizer Investigational Site
Teine, Hokkaido, Japan
Pfizer Investigational Site
Yokohama, Kanagawa, Japan
Pfizer Investigational Site
Yamashitachō, Naka-ku, Kanagawa-ken, Japan
Pfizer Investigational Site
Kita-ku, Osaka, Japan
Pfizer Investigational Site
Koshigaya-shi, Saitama, Japan
Pfizer Investigational Site
Chōfu, Tokyo, Japan
Pfizer Investigational Site
Kiyose, Tokyo, Japan
Pfizer Investigational Site
Setagaya-ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa-Ku, Tokyo, Japan
Pfizer Investigational Site
Shinagawa, Tokyo, Japan
Pfizer Investigational Site
Osaka, , Japan
Countries
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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A3841058
Identifier Type: -
Identifier Source: org_study_id
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